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A Clinical Trial of Taibowei® Adalimumab Injection in the Treatment of Chinese Pediatric Patients With Moderately to Severely Active Crohn's Disease

RecruitingPhase 4Ages 6 Years - 17 YearsAllChia Tai Tianqing Pharmaceutical Group Co., Ltd.
NCT07564505 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study is a real - world clinical research of adalimumab. The project plans to enroll 30 subjects, aiming to evaluate the incidence of serious adverse events (SAEs) within 12, 26, and 52 weeks after treatment; as well as the incidence of adverse events (AEs), adverse drug reactions (ADRs), adverse events of special interest (AESIs), and serious ADRs at 12, 26, and 52 weeks after treatment.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age is between 6 years old (inclusive) and 17 years old (inclusive), regardless of gender. * Diagnosed as having moderate - to - severe active pediatric Crohn's disease according to the "Expert Consensus on the Diagnosis and Treatment of Pediatric Inflammatory Bowel Disease 2019". * (3) Pediatric Crohn's disease patients who have been prescribed Adalimumab Solution for Injection by doctors after a full assessment of risks/benefits.Both the patient and their guardian must sign the informed consent form. The research protocol/informed consent form used for data collection and data verification should comply with local laws and regulatory requirements. Exclusion Criteria: * (1) According to the instruction manual of Adalimumab Solution for Injection and the judgment of the treating physician, the patient is not suitable for treatment with Adalimumab Solution for Injection. * (2) Pediatric Crohn's disease patients who have received any live vaccines within 3 months prior to the first dose of Adalimumab Solution for Injection or who plan to receive any live vaccines during the study period. * Patients who are participating in other clinical studies. (4) Patients whom the investigator deems unsuitable for participation in this trial.
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What it tests

  • Adalimumab Solution for Injection
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Where

1 site
Women and Children's Medical Center, Guangzhou Medical University
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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